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Senior QA Officer

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Waterford
  • Sector: Quality & Compliance
  • Date posted: 19/05/2017
  • Job reference: J365586A

Job Description

Senior Quality Assurance Officer to join the expanding QA team.

Job Purpose:

To support the Quality Assurance Manager and Quality Assurance Team Lead with the development, implementation and maintenance of the quality standards and systems to ensure that products comply with Marketing Authorisations, documentation, specifications and cGMPs.

Responsibilities:

  • To support the Quality Assurance Manager and Quality Assurance Team Lead with the quality assurance function.
  • Support manufacturing areas with QA support including but not limited to the following:

  1. Real time in situ batch documentation review
  2. Real time assessment of manufacturing events from a QA perspective.
  3. Provide clearance to precede instructions in manufacturing following unplanned events.
  • Electronic Documentation Management System - QUMAS
  1. Check own work and that of others for accuracy before / prior to 'QA Authorisation' of documentation.
  2. Print hard copy managed print documents such as BMR's.
  3. QA reviewer of Process Compliance Change Controls
  4. Progress process compliance actions and attach evidence as required.
  • Perform internal audits as scheduled in EirGen with specific responsibility for the manufacturing areas.
  • To ensure that all work carried out in EirGen is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  • Report any safety or compliance issues as per EirGen procedures.
  • Prepare and review batch packs for QA/ QP release as per procedure.
  • Liaise with operations / laboratory personnel to ensure regulatory and quality requirements are met.
  • Assist with review of Submission Documentation in support of license applications and customer requirements.
  • Noncompliance reporting and corrective action / continuous improvement implementation.
  • Operation of EirGen SAP (ERP System) Quality function as per procedures.
  • Support the on-going OOS/IR/CACI closeout programme.
  1. Complete any assigned actions in the agreed time frame.
  2. Investigate any incident assigned in a timely fashion.
  3. Review deviation investigations and actions as required.
  • To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  • Check own work and that of others for accuracy.
  • To assist in the preparation for customer/ regulatory inspections.
  • Attend a number of cross functional team meetings as a Quality Assurance representative
  • To perform additional team tasks as agreed to support effective running of the Business.
  • Compile and deliver quality based training with the company.

Minimum Qualifications & Experience

  • A third level degree incorporating Quality Assurance/ management. A standalone Quality Assurance or Quality management module may also fill this requirement.
  • Graduate with > 2 years experience in a Pharma role / GMP related role.
  • Experience with desktop and internet-based software applications (e.g. electronic document management system, MRP system) an advantage but not essential.
  • Excellent communication and presentation skills
  • Focus on quality and detail
  • Careful planning to achieve accurate and timely result
  • Ability to define and manage own tasks and schedules
  • Experience performing and assessing risk/impact assessment an advantage
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